Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin

NCT ID: NCT02700945

Last Updated: 2023-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 496 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2022-07-28

Brief Summary

The purpose of the Stroke AF study is to compare the incidence of atrial fibrillation (AF) through 12 months between continuous cardiac rhythm monitoring with the Reveal LINQ™ Insertable Cardiac Monitor (ICM) (continuous monitoring arm) and standard of care (SoC) medical treatment (control arm) in subjects with a recent ischemic stroke of presumed known origin.

Detailed Description

Stroke AF is a prospective, multi-site, randomized, controlled, non-blinded, post-market study. The Stroke AF study will compare the incidence rate of atrial fibrillation through 12 months between the continuous monitoring arm and the control arm in subjects with a recent ischemic stroke of presumed known origin. Subjects randomized to the continuous monitoring arm will have a Reveal LINQ Insertable Cardiac Monitor inserted within 10 days of the qualifying stroke and undergo continuous remote monitoring. Subjects randomized to the control arm will be followed per site specific standard of care.

Conditions

Stroke, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Reveal LINQ™ Insertable Cardiac Monitor

Subjects randomized to the Reveal LINQ™ Insertable Cardiac Monitor arm will be continuously monitored via the inserted Reveal LINQ™ device.

Group Type: ACTIVE_COMPARATOR

Reveal LINQ™ Insertable Cardiac Monitor

Intervention Type: DEVICE

The Medtronic Reveal LINQ™ ICM is a programmable device that continuously monitors a patient's ECG (electrocardiogram) and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient activation.

Control Arm

Subjects randomized to the control arm will be followed per site specific standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Reveal LINQ™ Insertable Cardiac Monitor

The Medtronic Reveal LINQ™ ICM is a programmable device that continuously monitors a patient's ECG (electrocardiogram) and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient activation.

Intervention Type: DEVICE

Other Intervention Names

LINQ; LINQ™

Eligibility Criteria

Inclusion Criteria

• Subject has had an ischemic stroke believed to be due to small vessel disease, large vessel cervical or intracranial atherosclerosis within the past 10 days
• Subject is willing and able to undergo study requirements and expected to be geographically stable during study follow-up
• Subject is 60 years of age or older, or age 50 to 59 years plus a documented medical history of at least one of the following additional risk factors for stroke:

• Congestive heart failure
• Hypertension (Systolic Blood Pressure > 140)
• Diabetes Mellitus
• Prior Stroke (>90 days ago, other than study qualifying index event)
• Vascular disease (e.g. coronary artery disease, heart attack, peripheral artery disease and complex aortic plaque)

Exclusion Criteria

• Subject has had a cryptogenic stroke
• Subject has had a cardioembolic stroke
• Subject has untreated hyperthyroidism
• Subject has had a recent myocardial infarction <1 month of stroke
• Subject has had a recent cardiac surgery (e.g. coronary artery bypass surgery (CABG)) <1 month of stroke
• Subject has a mechanical heart valve
• Subject has valvular disease requiring immediate surgical intervention
• Subject has documented prior history of atrial fibrillation or atrial flutter
• Subject has permanent indication for oral anticoagulation
• Subject has permanent contraindication to oral anticoagulation such that detection of AF would not change medical management, based on enrolling investigators judgment
• Subject is enrolled in a concurrent study that may confound the results of this study. Co-enrollment in any concurrent clinical study (including registries) requires approval of the study manager or designee.
• Subject's life expectancy is less than 1 year
• Subject is pregnant
• Subject has or is indicated for implant with a pacemaker, Implantable Cardioverter Defibrillator (ICD), Cardiac ResynchronizationTherapy (CRT), or an implantable hemodynamic monitor
• Subject with a medical condition that precludes the patient from participation in the opinion of the investigator

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Bernstein, PhD/MD

Role: STUDY_CHAIR

Northwestern University

Lee Schwamm, MD

Role: STUDY_CHAIR

Mass General

Locations

Cardiovascular Associates of the Southeast

Birmingham, Alabama, United States

Scripps Memorial Hospital La Jolla

La Jolla, California, United States

University of California San Francisco UCSF Medical Center

San Francisco, California, United States

Innovative Medical Research of South Florida

Aventura, Florida, United States

University of Miami Hospital

Miami, Florida, United States

AdventHealth Neuroscience Institute

Orlando, Florida, United States

The Queens Medical Center

Honolulu, Hawaii, United States

Northwestern University

Chicago, Illinois, United States

Baptist Health Lexington

Lexington, Kentucky, United States

Norton Neuroscience Institute

Louisville, Kentucky, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Health Partners Institute (Bloomington MN)

Bloomington, Minnesota, United States

Health Partners Institute (Saint Louis Park MN)

Saint Louis Park, Minnesota, United States

Cox Medical Center South

Springfield, Missouri, United States

Mercy Clinic Cardiology

St Louis, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Albany Medical Center

Albany, New York, United States

University at Buffalo, The State University of New York

Buffalo, New York, United States

North Shore University Hospital

New Hyde Park, New York, United States

NYU Langone Medical Center

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Overlook Medical Center

Summit, New York, United States

Cone Health

Greensboro, North Carolina, United States

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

PeaceHealth Sacred Heart Medical Center at Riverbend

Springfield, Oregon, United States

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, United States

Saint Thomas Research Institute

Nashville, Tennessee, United States

Baylor Research Institute Dallas - Baylor University Medical Center (BUMC)

Dallas, Texas, United States

University of Texas (UT) Southwestern Medical Center

Dallas, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Centra Medical Group Stroobants Cardiovascular Center

Lynchburg, Virginia, United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Countries

United States

References

Bernstein RA, Kamel H, Granger CB, Piccini JP, Katz JM, Sethi PP, Pouliot E, Franco N, Ziegler PD, Schwamm LH; STROKE AF Investigators. Atrial Fibrillation In Patients With Stroke Attributed to Large- or Small-Vessel Disease: 3-Year Results From the STROKE AF Randomized Clinical Trial. JAMA Neurol. 2023 Dec 1;80(12):1277-1283. doi: 10.1001/jamaneurol.2023.3931.

Reference Type: DERIVED

PMID: 37902733 (View on PubMed)

Schwamm LH, Kamel H, Granger CB, Piccini JP, Katz JM, Sethi PP, Sidorov EV, Kasner SE, Silverman SB, Merriam TT, Franco N, Ziegler PD, Bernstein RA; STROKE AF Investigators. Predictors of Atrial Fibrillation in Patients With Stroke Attributed to Large- or Small-Vessel Disease: A Prespecified Secondary Analysis of the STROKE AF Randomized Clinical Trial. JAMA Neurol. 2023 Jan 1;80(1):99-103. doi: 10.1001/jamaneurol.2022.4038.

Reference Type: DERIVED

PMID: 36374508 (View on PubMed)

Zachrison KS, Amati V, Schwamm LH, Yan Z, Nielsen V, Christie A, Reeves MJ, Sauser JP, Lomi A, Onnela JP. Influence of Hospital Characteristics on Hospital Transfer Destinations for Patients With Stroke. Circ Cardiovasc Qual Outcomes. 2022 May;15(5):e008269. doi: 10.1161/CIRCOUTCOMES.121.008269. Epub 2022 Apr 4.

Reference Type: DERIVED

PMID: 35369714 (View on PubMed)

Bernstein RA, Kamel H, Granger CB, Piccini JP, Sethi PP, Katz JM, Vives CA, Ziegler PD, Franco NC, Schwamm LH; STROKE-AF Investigators. Effect of Long-term Continuous Cardiac Monitoring vs Usual Care on Detection of Atrial Fibrillation in Patients With Stroke Attributed to Large- or Small-Vessel Disease: The STROKE-AF Randomized Clinical Trial. JAMA. 2021 Jun 1;325(21):2169-2177. doi: 10.1001/jama.2021.6470.

Reference Type: DERIVED

PMID: 34061145 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Stroke AF

Identifier Type: -

Identifier Source: org_study_id